Pascorbin 50 mg/ml solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Pascoe Pharmazeutische Präparate GmbH Schiffenberger Weg 55 35394 Giessen , Germany

ATC code:

A11GA01

INN (International Name):

ASCORBIC ACID 2.5 g

Pharmaceutical form:

SOLUTION FOR INJECTION/INFUSION

Composition:

ASCORBIC ACID 2.5 g

Prescription type:

POM

Therapeutic area:

VITAMINS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-07-03

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
_PASCORBIN 50 MG/ML_ SOLUTION FOR INJECTION/INFUSION
ascorbic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pascorbin
_ _
is and what it is used for
2.
What you need to know before you use Pascorbin
3.
How to use Pascorbin
4.
Possible side effects
5.
How to store Pascorbin
6.
Contents of the pack and other information
1.
WHAT PASCORBIN_ _IS AND WHAT IT IS USED FOR
Pascorbin is intended for the treatment of clinical vitamin C
deficiency states not amenable to
dietary supply or intake of vitamin C preparations, especially
-
endothelial dysfunction e.g. cardiovascular diseases
-
post-surgery or trauma
-
in critically ill patients
-
sepsis.
Pascorbin contains the essential active substance ascorbic acid
(vitamin C) that cannot be produced
internally by the human body.
Although our food contains all the vitamins the body needs, vitamin C
deficiency states may
develop in the elderly (more than 65 years of age), heavy alcohol
drinkers, smokers, pregnant
women and nursing mothers and in people with unbalanced dietary
habits.
Extremely low vitamin C levels in the white blood cells are observed
in patients with acute
infections,
severely
impaired
liver
function,
severe
injuries
(trauma,
burns,
major
surgical
procedures) and in hemodialysis patients.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PASCORBIN
DO NOT USE PASCORBIN:
-
if you are allergic to vitamin C or any of the other ingredients of
this medicine (listed in
secti

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Pascorbin 50 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial with 50 ml solution for injection/infusion contains: 2.5 g
ascorbic acid
The concentration is 50 mg/ml
Excipient with known effect:
Sodium hydrogen carbonate (50 ml of the product contains 324 mg
sodium).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, light yellow solution.
The pH ranges from 6.2 to 7.4 and osmolality is between 500 and 570
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of clinical vitamin C deficiency states not amenable to
dietary supply or oral replacement
therapy such as:
-
endothelial dysfunction e.g. cardio-circulatory pathologies
-
post-surgery or trauma
-
in critically ill patients
-
sepsis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults: _
The usual dose is 0.5 to 1.0 g ascorbic acid (corresponding to 10 –
20 ml solution).
Depending on the disease situation, up to 3 g ascorbic acid per day
may be used for infusion.
In studies with patients with the claimed indications, the following
dosages have been shown to be
effective:
- Endothelial dysfunction: 1 - 3 g (20 – 60 ml)
- Post-surgery, after trauma and in critically ill patients: 2-3 g
(40- 60 ml).
- Sepsis: At least 1.5 g (30 ml)
Single doses of more than 1 vial are possible (see section 6.3 and
6.6).
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_Paediatric population: _
Children under 12 years of age should not receive more than 5-7 mg
ascorbic acid/kg body weight
per day. High doses of Pascorbin are contraindicated in children under
12 years (see section 4.3).
Method of administration
For intravenous injection or infusion.
The injection/infusion therapy must be performed by a physician.
The duration of use depends on the course of the illness and the
results of laboratory tests.
4.3
CONTRAINDICATIONS
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Hypersensitivity to the active substance or to any of the excipien